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Shoulder dystocia is an obstetrical complication that occurs in approximately 30,000 deliveries in the US every year. In this medical emergency, the child’s head

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

is able to clear the cervix, but the shoulders become impacted behind the mother’s pelvis. This impaction may prevent a vaginal delivery. In such cases, the bab

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

y’s face will exhibit what is known as a turtle sign, where the head appears to be pulled back tightly against the vulva. This is generally the first sign that t

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ere is a problem. The fear is that if the shoulder is not quickly dislodged, the baby is not able to breathe because the vaginal canal is compressing against the

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

baby’s chest. Additional maneuvers are then required to properly deliver the baby.

When this occurs, most physicians initially perform a variety of conservativ

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e procedures to free the baby’s shoulders. These procedures are part of the standard of care in deliveries where shoulder dystocia occurs, and may include:

· th

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

McRobert’s maneuver, where the mother’s thighs are hyperflexed to widen the pelvic outlet
· Gaskin maneuver where the mother is placed into an all fours po

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

sition on her hands and knees. This may not be possible in cases involving epidural anesthesia.
· Rubin I, where suprapubic pressure is applied to the moth

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

er’s pubic bone, to rotate and dislodge the shoulder under the pubis symphysis.
· Rubin II, where posterior pressure is placed on the anterior shoulder

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

· Woods maneuver, where the physician inserts a hand to rotate the fetus either way to facilitate delivery
· Jacquemier’s (or Barnum’s) maneuver, where the

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

posterior shoulder is delivered up and over the chest, then the shoulder and the rest of the baby, and
· Zavanelli’s maneuver, which is the most dangerous

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

and used as a last resort. This involves pushing the baby’s head back into the vagina and performing a caesarean section.

The incidence of shoulder dystoci

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

may lead to more serious injury, and may include:

· fractures of the clavicle (sometimes intentional to clear the cervix)
· fractures of the humerus (some

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

times intentional to clear the cervix)
· temporary or permanent injury involving the brachial plexus nerves (brachial plexus injury or Erb’s Palsy) that att

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ach to the spine in the upper, middle and lower trunk, and run through the shoulder and down to the arms and hands.
· hypoxia leading to brain damage or

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

· death

Deliveries with shoulder dystocia occur in both diabetic and non-diabetic mothers. The incidence is greater in diabetic mothers who deliver larger

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

babies. If you are at high risk for delivering a baby with shoulder dystocia, your health care provider should perform an ultrasound to determine if the baby’s

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

size will be a problem. Your physician should also discuss if a large episiotomy will be necessary or if a planned caesarean section will be the best way to safe

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

uard the health of the child. Caesarean sections are not always the practical solution for all cases, but if the birth weight of the infant is high (macrosomia),

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

maternal obesity exists, the mother has gestational diabetes, and/or there is a previous history of shoulder dystocia, then a caesarean section may be indicated

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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